Life Saving Drugs Program Expert Panel

Page last updated: 10 May 2019

An Expert Panel for the Life Saving Drugs Program (LSDP) has been established to provide assistance and advice to the Commonwealth Chief Medical Officer (CMO). The Expert Panel will consider and advise on both new medicine applications and reviews of existing medicines. This advice will support the CMO in the development of recommendations to the Commonwealth Minister for Health on the suitability of medicines for funding (either new or ongoing) under the LSDP. The Expert Panel includes suitably qualified experts including a consumer representative, an industry nominee, a health economist and clinicians.

Terms of Reference

1. The Expert Panel provides advice the CMO on a range of matters relating to new medicines seeking funding through the LSDP, including:

assessment of how the medicine addresses the LSDP criteria;

guidelines for use, including testing requirements;

pricing arrangements; and

data collection requirements for future review.

2. In reviewing LSDP medicines, the Expert Panel will:

Determine the scope of the review;

Ensure relevant stakeholder input is included;

Review historical patient level data in addition to any data available from international registries and in published literature; and

Provide advice to the CMO regarding any appropriate changes to medicine funding arrangements.

3. The Expert Panel will advise on any other matter that may relate to the LSDP as directed by the Minister or CMO.

Current Membership

Professor Andrew Roberts – CHAIR
Professor Roberts is an eminent researcher and clinical haematologist. He currently practices at the Royal Melbourne Hospital and Peter MacCallum Cancer Centre. Professor Roberts also served as a member of the Pharmaceutical Benefits Advisory Committee (PBAC) for eleven years.

Professor Jonathan Craig - CLINICAL EXPERT.
Professor Craig is Vice President and Executive Dean at the College of Medicine and Public Health, Flinders University and is a current member of Pharmaceutical Benefits Advisory Committee.

Dr James Butler – HEALTH ECONOMIST
Dr Butler works as a health economics consultant and currently sits on the Commonwealth’s Prostheses List Advisory Committee and its Health Economics Sub Committee.

Expert Panel meeting agenda

The Expert Panel meets three times per year, usually February, June and October.

The agenda of the LSDP Expert Panel will be published four weeks in advance of the meeting and will list all items that will be considered at the upcoming meeting. This includes new medicines for funding under the LSDP and consideration of outcomes from LSDP medicine reviews.

Current Meeting Agenda

Previous Meeting Agendas

Expert Panel Stakeholder Forum

A Stakeholder Forum will be conducted during the consideration of a new medicine or the review of existing medicines, where stakeholders such as sponsors, consumer and clinicians are invited to provide their views to the Expert Panel.

Expert Panel consumer submissions

Once the agenda for the upcoming Expert Panel meeting is published, any interested parties are welcome to provide their input directly to the LSDP Expert Panel Secretariat via email. Contact the LSDP Expert Panel Secretariat if you would like to be notified of any changes to the LSDP webpages, including when meeting agendas are published.

Stakeholder input is kept confidential on request. Full details around the consumer submission process can be found in the Procedure Guidance document on the main LSDP webpage.

For new medicines

Public submissions to the Panel are welcomed in the Expert Panel’s consideration of the needs of, and benefits to, patients living with the rare disease being discussed. These can be from any member of the public: patient, family member, carer, physician, advocate, etc.

As all medicines to be considered by the LSDP Expert Panel will have already been considered by the PBAC for listing on the PBS, all consumer comments received throughout the corresponding PBAC process will be made available to the Panel. Stakeholders do not need to duplicate responses.

For reviews of existing LSDP medicines

There are multiple opportunities for consumer input throughout the review of existing medicines:

When the Panel considers the draft Terms of Reference

After the draft Terms of Reference have been published

During the stakeholder forum. This is usually held on the day of the scheduled Expert Panel meeting, after the terms of reference have been endorsed by the CMO. Forums are based on discussion questions that have been developed in consultation with the Expert Panel.

The flowchart below provides an overview of the review process.

Submission Timings

Once the Expert Panel meeting agenda has been published, any interested parties are welcome to provide their input directly to the LSDP Secretariat via email.

This input must be provided two weeks prior to the Expert Panel meeting to be considered.

Review Protocol
A stakeholder forum to discuss the Fabry disease medicine review protocol was held in Melbourne on 21 February 2019. Stakeholders made a number of comments which were considered by the Expert Panel. The Summary of Changes to the Draft Review Protocol and the finalised Review Protocol are available below.

A Stakeholder forum to discuss the Gaucher disease medicine review protocol was held in Sydney on 22 February 2019. Stakeholders made a number of comments which were considered by the Expert Panel. The Summary of Changes to the Draft Review Protocol and the finalised Review Protocol are available below.

Due to its limited utilisation, miglustat (Zavesca®) will not be assessed with the other Gaucher disease medicines, and will instead undergo a separate review by the Department. The miglustat Review Plan has been finalised by the LSDP Expert Panel and is available below.